Authors
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Best Practices for Design and Operation of Multiproduct Manufacturing FacilitiesCareful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.
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Designing Commercial-Scale Oligonucleotide SynthesisConsider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
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Designing Commercial-Scale Oligonucleotide SynthesisConsider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
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Designing Commercial-Scale Oligonucleotide SynthesisConsider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
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Digitalization: A CDMO’s PerspectiveCDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.
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How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein CharacterizationComplex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.
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Quantitative Rupture Testing of Soft Gelatin Capsules: Understanding Aberrant ResultsThis paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.
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Building a Business Case for Quality Management TransformationCan the pharmaceutical industry embrace the goals of Quality 4.0?
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Using the ‘Cubic Effect’ to Drive Cell and Gene Therapy CommercializationContract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.
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Establishing and Maintaining an Effective Gas Evaluation and Management ProgramThe author examines the challenges that arise in ordering, storing, and using gas supplies for the pharmaceutical laboratory, and suggests solutions to these difficulties.
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Using AI for CAPA and Root-Cause Investigations*Thursday, May 6, 2021 at 2pm EDT | 1pm CDT | 11am PDT* Learn how artificial intelligence can be used to investigate corrective and preventive actions, pinpoint the root cause of the most common complaints, tell if training is effective, and identify the combination of materials and workers to increase production. *On Demand Until May 6, 2022*
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The MALDImini-1: Entering the Digital Age in MSThe first-of-its-kind MALDImini-1 digital ion trap mass spectrometer targets comprehensive structural analyses applications. It is the only device capable of MALDI-MSn on the compact footprint of an A3-sized paper.
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Common Cleanroom MythsMyths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.
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Common Cleanroom MythsMyths and misunderstanding abound when it comes to microbiology. When it comes to cleanroom and pharmaceutical microbiology, some “myths” have become engrained and even endorsed by regulatory bodies. The authors use logic and sound science to dispel some Microbiological Myths related to Disinfectant Cleaning of Controlled Environments.
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Critical Requirements of the Mid Range Table PressTablet press design innovation has traditionally centered on large-scale production equipment, however, there is increasing focus on the smaller-scale, mid-range models that must have the capability to support product development, scale-up, tech transfer, clinical batch manufacturing, small and medium batch production, and continuous manufacturing applications. This range of capabilities demands unique features and design flexibility.
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Cultural Transformations a Necessity to Support Complex Therapeutics Through Development and ManufacturingPresident and CEO of Pharmaceutics International, Inc. (Pii), John Fowler, reacts to the agility and flexibility needed to support the development and manufacture of today's complex biotherapeutics.
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ADVANCEMENTS IN GLP-1 ANALOG FORMULATION DEVELOPMENT: OVERCOMING CHALLENGES IN ORAL DELIVERYObesity is a significant global health challenge that requires lifestyle changes and effective pharmacological treatments to overcome. Human glucagon-like peptide 1 (GLP-1) analogs, also called incretin mimetics, have emerged as a promising obesity treatment option. Additionally, oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering greater patient comfort and adherence to expand the therapeutic market.
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Federal Equipment Company: Supporting CDMO Operations Through Training, Parts, and EquipmentAdam Covitt, President of Federal Equipment Company, discusses how the company enables CDMO successes with its Techceuticals and PharmParts business brands.
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Implementation of Autocorners Algorithm for Retrospective Process MonitoringThe authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
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Implementation of Autocorners Algorithm for Retrospective Process MonitoringThe authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
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Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1: A Science-Based Holistic ApproachWebinar Date/Time: Tuesday, February 28th, 2023 at 11am EST | 8am PST | 4pm GMT | 5pm CET
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Integrated Pre-Formulation Studies for Fast Advancement of Drug Candidates to Human Clinical StudiesLooking for a fast pathway to an investigational new drug application (IND) for your new drug candidates? This webcast will discuss strategies to select the most developable molecules and quickly develop an IND-ready formulation within 8–12 weeks using real-world case studies. Live: Wednesday, April 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Apr. 15, 2021 Register free
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Booming Biotech: Five Start-Ups to Watch in CambridgeAccording to recent figures, Cambridge’s technology sector is booming and the city is emerging as a hub for biotech companies.
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Optimizing Equipment Availability for Capsule FillersLearn what the common equipment bottlenecks are and how engineering developments can maximize equipment availability. Experts will provide insight into how to minimize cycle, set-up, and changeover times and how to define optimal parameters for each process step. Live: Tuesday, Mar. 24, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET On demand available after airing until Mar. 24, 2021 Register free
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
